Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612580
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
68Ga-AAZTA-NI-093 PETCT First-in-human Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
68Ga-AAZTA-NI-093 PETCT First-in-human Study in Patients With Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazoleNI-moiety and a PSMA-targeting In this study we observed the safety biodistribution radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PETCT in patients with prostate cancer
Detailed Description:
Prostate cancer PCa is one of the most common malignancies worldwide in men Prostate specific membrane antigen PSMA as known as folate hydrolase I or glutamate carboxypeptidase II is overexpressed on the cells of prostatic adenocarcinoma Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11 PSMA-617 for 68Ga- or 177Lu- labeling have been developed 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazoleNI-moiety and a PSMA-targeting This pilot study was prospectively designed to evaluate the safety biodistribution radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PETCT in prostate cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None